Submission for OMB Review; Assessing Models of Coordinated Services for Low-Income Children and Their Families (AMCS) (0970-0535), 57216-57217 [2020-20266]
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Federal Register / Vol. 85, No. 179 / Tuesday, September 15, 2020 / Notices
To obtain copies of a supporting
statement and any related forms for the
proposed collection(s) summarized in
this notice, you may make your request
using one of following:
1. Access CMS’ website address at
website address at https://www.cms.gov/
Regulations-and-Guidance/Legislation/
PaperworkReductionActof1995/PRAListing.html.
2. Call the Reports Clearance Office at
(410) 786–1326.
FOR FURTHER INFORMATION CONTACT:
William N. Parham at (410) 786–4669.
SUPPLEMENTARY INFORMATION:
Contents
This notice sets out a summary of the
use and burden associated with the
following information collections. More
detailed information can be found in
each collection’s supporting statement
and associated materials (see
ADDRESSES).
CMS–P–0015A Medicare Current
Beneficiary Survey
Under the PRA (44 U.S.C. 3501–
3520), federal agencies must obtain
approval from the Office of Management
and Budget (OMB) for each collection of
information they conduct or sponsor.
The term ‘‘collection of information’’ is
defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA
requires federal agencies to publish a
60-day notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension or reinstatement of an existing
collection of information, before
submitting the collection to OMB for
approval. To comply with this
requirement, CMS is publishing this
notice.
jbell on DSKJLSW7X2PROD with NOTICES
Information Collection
1. Type of Information Collection
Request: Revision of a currently
approved collection; Title of
Information Collection: Medicare
Current Beneficiary Survey; Use: CMS is
the largest single payer of health care in
the United States. The agency plays a
direct or indirect role in administering
health insurance coverage for more than
120 million people across the Medicare,
Medicaid, CHIP, and Exchange
populations. A critical aim for CMS is
to be an effective steward, major force,
and trustworthy partner in supporting
innovative approaches to improving
quality, accessibility, and affordability
in healthcare. CMS also aims to put
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patients first in the delivery of their
health care needs.
The Medicare Current Beneficiary
Survey (MCBS) is the most
comprehensive and complete survey
available on the Medicare population
and is essential in capturing data not
otherwise collected through our
operations. The MCBS is a nationallyrepresentative, longitudinal survey of
Medicare beneficiaries that we sponsor
and is directed by the Office of
Enterprise Data and Analytics (OEDA).
The survey is usually conducted inperson but can also be conducted by
phone. It captures beneficiary
information whether aged or disabled,
living in the community or facility, or
serviced by managed care or fee-forservice. Data produced as part of the
MCBS are enhanced with our
administrative data (e.g., fee-for-service
claims, prescription drug event data,
enrollment, etc.) to provide users with
more accurate and complete estimates of
total health care costs and utilization.
The MCBS has been continuously
fielded for more than 28 years,
encompassing over 1 million interviews
and more than 100,000 survey
participants. Respondents participate in
up to 11 interviews over a four-year
period. This gives a comprehensive
picture of health care costs and
utilization over a period of time.
The MCBS continues to provide
unique insight into the Medicare
program and helps CMS and our
external stakeholders better understand
and evaluate the impact of existing
programs and significant new policy
initiatives. In the past, MCBS data have
been used to assess potential changes to
the Medicare program. For example, the
MCBS was instrumental in supporting
the development and implementation of
the Medicare prescription drug benefit
by providing a means to evaluate
prescription drug costs and out-ofpocket burden for these drugs to
Medicare beneficiaries. Beginning in
2021, this proposed revision to the
clearance will add a few new measures
to existing questionnaire sections and
will add a new COVID–19
Questionnaire section previously
approved by OMB on August 7, 2020
under Emergency Clearance 0938–1379.
The revisions will result in an increase
in respondent burden due to the
addition of the new items. Form
Number: CMS–P–0015A (OMB control
number: 0938–0568); Frequency:
Occasionally; Affected Public: Business
or other for-profits and Not-for-profit
institutions; Number of Respondents:
13,656; Total Annual Responses:
35,998; Total Annual Hours: 53,176.
(For policy questions regarding this
PO 00000
Frm 00036
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collection contact William Long at 410–
786–7927.)
Dated: September 9, 2020.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2020–20273 Filed 9–14–20; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Submission for OMB Review;
Assessing Models of Coordinated
Services for Low-Income Children and
Their Families (AMCS) (0970–0535)
Office of Planning, Research,
and Evaluation; Administration for
Children and Families; Health and
Human Services (HHS).
ACTION: Request for public comment.
AGENCY:
The Office of Planning,
Research, and Evaluation (OPRE),
Administration for Children and
Families (ACF), U.S. Department of
Health and Human Services (HHS), is
requesting an extension to continue
collecting data for the study, Assessing
Models of Coordinated Services for
Low-Income Children and Their
Families (AMCS). Data collection has
been delayed due to the COVID–19
pandemic and will not be complete by
the current expiration date of October
31, 2020. There are no changes
proposed to the current instruments.
DATES: Comments due within 30 days of
publication. OMB must make a decision
about the collection of information
between 30 and 60 days after
publication of this document in the
Federal Register. Therefore, a comment
is best assured of having its full effect
if OMB receives it within 30 days of
publication.
SUMMARY:
Written comments and
recommendations for the proposed
information collection should be sent
within 30 days of publication of this
notice to www.reginfo.gov/public/do/
PRAMain. Find this particular
information collection by selecting
‘‘Currently under 30-day Review—Open
for Public Comments’’ or by using the
search function.
SUPPLEMENTARY INFORMATION:
Description: Through AMCS, ACF
seeks to learn more about how states
and communities coordinate early care
and education, family economic
security, and/or other health and human
ADDRESSES:
E:\FR\FM\15SEN1.SGM
15SEN1
57217
Federal Register / Vol. 85, No. 179 / Tuesday, September 15, 2020 / Notices
services to most efficiently and
effectively serve the needs of lowincome children and their families. ACF
aims to understand strategies used to
support partnerships, including the
federal barriers to agency collaboration.
In support of achieving these goals, the
study team is conducting ‘‘virtual site
visits’’ with six programs that offer
coordinated services. The study team
will gather information through
interviews with program staff members,
such as agency leaders or frontline staff,
and focus groups with parents.
Data collection activities will include
up to six program ‘‘virtual site visits.’’
‘‘Virtual site visits’’ include semistructured interviews with up to 30 total
staff at each site and focus groups with
8–10 parents at each site. Semistructured interviews with program and
partner staff will obtain in-depth
information about the goals and
objectives of programs, the services
provided, how the coordinated services
are implemented, how staffing is
managed, data use, and any facilitators
and barriers to coordination. Focus
groups with parents participating in the
program will provide the opportunity to
learn about how parents perceive the
program; how it meets their needs; what
benefits they gain from the program; and
how they enroll, participate, and
progress through the program.
Respondents: Lead program and
partner program staff members working
in six programs across the United States
that coordinate early care and education
services with family economic security
services and/or other health and human
services, as well as parents receiving
services from these programs. Staff
respondents will be selected with the
goal of having staff represent each level
of the organization. Parents who have
participated in the program for at least
6 months and who receive early
childhood services and at least one
other program service will be invited to
participate in focus groups.
ANNUAL BURDEN ESTIMATES
Total/annual
number of
respondents
Instrument
Master Virtual Site Visit Interview Protocol .....................................................
Parent Virtual Focus Group Protocol ...............................................................
Authority: 42 U.S.C. 9858(a)(5).
John M. Sweet, Jr.,
ACF/OPRE Certifying Officer.
[FR Doc. 2020–20266 Filed 9–14–20; 8:45 am]
BILLING CODE 4184–23–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–N–1153]
Post-Marketing Pediatric-Focused
Product Safety Reviews;
Establishment of a Public Docket;
Request for Comments; Correction
Food and Drug Administration,
Health and Human Services (HHS).
ACTION: Notice; correction.
AGENCY:
The Food and Drug
Administration (FDA) is correcting a
notice that appeared in the Federal
Register of September 2, 2020. The
document announced the availability of
post-marketing pediatric-focused safety
reviews of products posted between
September 23, 2019, and September 1,
2020, on FDA’s website but not
presented at the September 15, 2020,
Pediatric Advisory Committee meeting.
The document was published with the
incorrect product name for one of the
post-marketing pediatric-focused safety
reviews listed under Center for
jbell on DSKJLSW7X2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
16:57 Sep 14, 2020
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180
60
Biologics Evaluation and Research. This
document corrects that error.
FOR FURTHER INFORMATION CONTACT:
Marieann Brill, Office of the
Commissioner, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 32, Rm. 5154, Silver Spring,
MD 20993, 240–402–3838.
SUPPLEMENTARY INFORMATION:
Estimated Total Annual Burden
Hours: 420.
Correction
In the Federal Register of September
2, 2020 (85 FR 54580), appearing on
page 54580 in FR Doc. 2020–19835, the
following correction is made:
On page 54581, in the first column,
under Center for Biologics Evaluation
and Research, ‘‘9. QPAN H5N1 Vaccine
(Influenza A (H5N1) virus monovalent
vaccine, adjuvanted)’’ is corrected to
read ‘‘9. Influenza A (H5N1) Virus
Monovalent Vaccine, Adjuvanted.’’
Dated: September 9, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–20329 Filed 9–14–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–N–0026]
Issuance of Priority Review Voucher;
Rare Pediatric Disease Product
Food and Drug Administration,
Health and Human Services (HHS).
AGENCY:
PO 00000
Frm 00037
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Sfmt 4703
Number of
responses per
respondent
Average
burden hours
per response
1
1
ACTION:
2
1
Annual
burden hours
360
60
Notice.
The Food and Drug
Administration (FDA) is announcing the
issuance of a priority review voucher to
the sponsor of a rare pediatric disease
product application. The Federal Food,
Drug, and Cosmetic Act (FD&C Act), as
amended by the Food and Drug
Administration Safety and Innovation
Act (FDASIA), authorizes FDA to award
priority review vouchers to sponsors of
approved rare pediatric disease product
applications that meet certain criteria.
FDA is required to publish notice of the
award of the priority review voucher.
FDA has determined that TRIKAFTA
(elexacaftor/tezacaftor/ivacaftor),
manufactured by Vertex
Pharmaceutical, Inc., meets the criteria
for a priority review voucher.
FOR FURTHER INFORMATION CONTACT:
Althea Cuff, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Silver Spring, MD 20993–0002,
301–796–4061, Fax: 301–796–9856,
email: althea.cuff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: FDA is
announcing the issuance of a priority
review voucher to the sponsor of an
approved rare pediatric disease product
application. Under section 529 of the
FD&C Act (21 U.S.C. 360ff), which was
added by FDASIA, FDA will award
priority review vouchers to sponsors of
approved rare pediatric disease product
applications that meet certain criteria.
FDA has determined that TRIKAFTA
(elexacaftor/tezacaftor/ivacaftor),
SUMMARY:
E:\FR\FM\15SEN1.SGM
15SEN1
Agencies
[Federal Register Volume 85, Number 179 (Tuesday, September 15, 2020)]
[Notices]
[Pages 57216-57217]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-20266]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Submission for OMB Review; Assessing Models of Coordinated
Services for Low-Income Children and Their Families (AMCS) (0970-0535)
AGENCY: Office of Planning, Research, and Evaluation; Administration
for Children and Families; Health and Human Services (HHS).
ACTION: Request for public comment.
-----------------------------------------------------------------------
SUMMARY: The Office of Planning, Research, and Evaluation (OPRE),
Administration for Children and Families (ACF), U.S. Department of
Health and Human Services (HHS), is requesting an extension to continue
collecting data for the study, Assessing Models of Coordinated Services
for Low-Income Children and Their Families (AMCS). Data collection has
been delayed due to the COVID-19 pandemic and will not be complete by
the current expiration date of October 31, 2020. There are no changes
proposed to the current instruments.
DATES: Comments due within 30 days of publication. OMB must make a
decision about the collection of information between 30 and 60 days
after publication of this document in the Federal Register. Therefore,
a comment is best assured of having its full effect if OMB receives it
within 30 days of publication.
ADDRESSES: Written comments and recommendations for the proposed
information collection should be sent within 30 days of publication of
this notice to www.reginfo.gov/public/do/PRAMain. Find this particular
information collection by selecting ``Currently under 30-day Review--
Open for Public Comments'' or by using the search function.
SUPPLEMENTARY INFORMATION:
Description: Through AMCS, ACF seeks to learn more about how states
and communities coordinate early care and education, family economic
security, and/or other health and human
[[Page 57217]]
services to most efficiently and effectively serve the needs of low-
income children and their families. ACF aims to understand strategies
used to support partnerships, including the federal barriers to agency
collaboration. In support of achieving these goals, the study team is
conducting ``virtual site visits'' with six programs that offer
coordinated services. The study team will gather information through
interviews with program staff members, such as agency leaders or
frontline staff, and focus groups with parents.
Data collection activities will include up to six program ``virtual
site visits.'' ``Virtual site visits'' include semi-structured
interviews with up to 30 total staff at each site and focus groups with
8-10 parents at each site. Semi-structured interviews with program and
partner staff will obtain in-depth information about the goals and
objectives of programs, the services provided, how the coordinated
services are implemented, how staffing is managed, data use, and any
facilitators and barriers to coordination. Focus groups with parents
participating in the program will provide the opportunity to learn
about how parents perceive the program; how it meets their needs; what
benefits they gain from the program; and how they enroll, participate,
and progress through the program.
Respondents: Lead program and partner program staff members working
in six programs across the United States that coordinate early care and
education services with family economic security services and/or other
health and human services, as well as parents receiving services from
these programs. Staff respondents will be selected with the goal of
having staff represent each level of the organization. Parents who have
participated in the program for at least 6 months and who receive early
childhood services and at least one other program service will be
invited to participate in focus groups.
Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
Total/annual Number of Average burden
Instrument number of responses per hours per Annual burden
respondents respondent response hours
----------------------------------------------------------------------------------------------------------------
Master Virtual Site Visit Interview Protocol.... 180 1 2 360
Parent Virtual Focus Group Protocol............. 60 1 1 60
----------------------------------------------------------------------------------------------------------------
Estimated Total Annual Burden Hours: 420.
Authority: 42 U.S.C. 9858(a)(5).
John M. Sweet, Jr.,
ACF/OPRE Certifying Officer.
[FR Doc. 2020-20266 Filed 9-14-20; 8:45 am]
BILLING CODE 4184-23-P